華仁藥業(300110.SZ)：多索茶鹼注射液補充規格取得藥品註冊證書
格隆匯12月23日丨華仁藥業(300110.SZ)公佈，公司子公司安徽恆星製藥有限公司(以下簡稱“安徽恆星製藥”)收到國家藥品監督管理局核准簽發的“多索茶鹼注射液20ml：0.2g規格”的《藥品補充申請批准通知書》，申請內容：藥學研究信息：本品申請在原規格(10ml∶0.1g)的基礎上增加與其同濃度的20ml∶0.2g的規格。
多索茶鹼注射液適用於支氣管哮喘，慢性喘息性支氣管炎及其他支氣管痙攣引起的呼吸困難，為國家醫保乙類品種。多索茶鹼是甲基黃嘌呤的衍生物，是一種支氣管擴張劑，可直接作用於支氣管，通過抑制平滑肌細胞內的磷酸二酯酶，鬆弛支氣管平滑肌，從而達到抑制哮喘的作用。
多索茶鹼注射液最早由意大利Abc Farmaceutici SPA公司開發，並於1988年在意大利批准上市，2013年在國內批准上市。在國內，目前有13家公司取得該品種註冊批件(含安徽恆星製藥)，其中：10ml：0.1g規格13家，20ml：0.2g規格2家(數據來源：國家藥品監督管理局藥品審評中心)。
根據米內網數據統計，2020年多索茶鹼注射液在中國城市公立醫院銷售額為37,104萬元，2021年一季度多索茶鹼注射液在中國城市公立醫院銷售額為19,100萬元，子公司安徽恆星製藥市場佔有率排名第四位。
子公司安徽恆星製藥高度重視藥品研發，並嚴格控制藥品研發、製造及銷售環節的質量及安全。2021年，安徽恆星製藥多索茶鹼注射液10ml:0.1g規格通過一致性評價，並中標第四批國家集採，銷售規模大幅增長。本次增加多索茶鹼注射液20ml：0.2g規格並取得藥品註冊批件，將進一步豐富公司的產品線，優化產品結構，對公司發展具有積極影響。但未來銷售情況受醫藥行業政策變動、國家集採、市場環境變化、市場推廣因素影響，具有不確定性。
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